MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ATLAS GOLD; PTA BALLOON DILATATION CATHETER

Catalog Number	ATG120144
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an angioplasty procedure for the stenosis of the right anterior venous trunk, the balloon allegedly detached from the catheter and remained partially inflated at the interior of the vena cava.It was further reported that there were difficulties in retracting the device as the balloon was detached from the catheter shaft and became stuck at the partially swollen treatment site.Reportedly, the balloon was completely removed from the patient using vascular snare and biopsy forceps.There was no reported patient injury.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 01/2026).H11: section a through f: the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : device not returned.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.Six photos were provided by the customer and reviewed.First four images and the sixth image show the balloon has been completely detached and retrieved by snare retriever tool.Fifth photo shows the balloon can be seen detached completely from the catheter exposing the inner guide wire lumen and the detached balloon was retrieved by using the snare retriever tool.No other anomalies noted.As the submitted photos show the evidence of balloon detachment and the detached balloon was retrieved with the snare retriever tool.Therefore, the investigation confirmed for the reported balloon detachment and identified removal difficulty of detached balloon.However, the investigation remains inconclusive for the balloon entrapment as no objective evidence was observed on the submitted photos.A definitive root cause for the reported entrapment, detachment issue and identified difficult to remove issue could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: b5, d4 (expiry date: 01/2026), g3, h6 (method).H11: section a through f: the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that during an angioplasty procedure in right anterior venous, the balloon allegedly had detached from the catheter and remained partially inflated at the interior of the vena cava.It was further reported that the balloon was allegedly stuck in the partially swollen treatment site.Reportedly, the balloon had to be deflated with serrated biopsy forceps by tearing the balloon and the balloon was retrieved via a loop catheter.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure in right anterior venous, the balloon allegedly had detached from the catheter and remained partially inflated at the interior of the vena cava.It was further reported that the balloon was allegedly stuck in the partially swollen treatment site.Reportedly, the balloon had to be deflated with serrated biopsy forceps by tearing the balloon and the balloon was retrieved via a loop catheter.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.Six photos were provided by the customer and reviewed.First four images and the sixth image show the balloon has been completely detached and retrieved by snare retriever tool.Fifth photo shows the balloon can be seen detached completely from the catheter exposing the inner guide wire lumen and the detached balloon was retrieved by using the snare retriever tool.No other anomalies noted.As the submitted photos show the evidence of balloon detachment and the detached balloon was retrieved with the snare retriever tool.Therefore, the investigation confirmed for the reported balloon detachment and identified removal difficulty of detached balloon.However, the investigation remains inconclusive for the balloon entrapment as no objective evidence was observed on the submitted photos.A definitive root cause for the reported entrapment, detachment issue and identified difficult to remove issue could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H11: section a through f: the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: ATLAS GOLD
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): FUTUREMATRIX INTERVENTIONAL; 1605 enterprise street; athens 75751
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18241106
• Report Number: 2020394-2023-01118
• Device Sequence Number: 6983912
• Product Code: DQY
• UDI-Device Identifier: 00801741060762
• UDI-Public: (01)00801741060762(11)230119(17)260119(10)93NH0154
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K181323
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/19/2026
• Device Catalogue Number: ATG120144
• Device Lot Number: 93NH0154
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2023
• Supplement Date Received by Manufacturer: 01/18/2024; 06/13/2024
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 01/22/2024; 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/19/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown